MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device intermittently won't power on.As a result, defibrillation therapy may be delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device intermittently won't power on.As a result, defibrillation therapy may be delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The original medwatch report was submitted in error and is a duplicate of report # 0003015876-2020-01648.

• Brand Name: LIFEPAK 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10835429
• Report Number: 0003015876-2020-01714
• Device Sequence Number: 4012074
• Product Code: MKJ
• UDI-Device Identifier: 00883873911785
• UDI-Public: 00883873911785
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1